Acetaminophen Versus IV Hydromorphone for Pain in the Elderly in the ED

An ED-based Randomized Trial of IV Acetaminophen Versus IV Hydromorphone for Elderly Adults With Acute Severe Pain

Intravenous opioids are the mainstay of acute, severe pain treatment in Emergency Departments (ED) across the country. Acetaminophen, given orally, has also been used for treatment of mild to moderate pain. The more potent intravenous (IV) form of acetaminophen has been widely used in Europe for more than 20 years as post-surgical analgesia and received full FDA approval in the USA in 2010. As part of a continuing set of studies whose goal is to optimize treatment of pain among elderly ED patients, this randomized study will compare efficacy and safety of IV acetaminophen to IV hydromorphone.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: Acetaminophen 1000mg IV; Drug: Hydromorphone 0.5 mg IV

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age equal to 65 or greater
2. Pain onset within 7 days with severe pain
3. Has capacity to provide informed consent
4. Understanding English or Spanish

Exclusion Criteria:

1. Use of tramadol or opioids within 7 days
2. Use of acetaminophen or non-steroidal anti-inflammatory medications within 8 hours
3. Chronic pain syndrome: daily pain for > 3 months. Sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies
4. Conditions which may affect acetaminophen or opioid metabolism such as cirrhosis (Child Pugh A or worse), kidney impairment (CKD 3 or worse), active hepatic disease or severe dehydration
5. Alcohol intoxication
6. Systolic blood pressure: < 100 mmHg
7. Heart rate: < 60 beats per minute
8. Oxygen saturation: < 95% on room air
9. Use of monoamine oxidase (MAO) inhibitors in the past 30 days
10. Use of transdermal pain patch or oral opioid > 10 days in the prior month
11. Prior enrollment in the same study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acetaminophen 1000mg IV; NRS pain score will be obtained at baseline, 15, 30, 45, 60, 90, 120, and 180 minutes following completion of intervention. Adverse events will be recorded every 15 minutes for the duration of the study protocol. Participants will be reassessed for the need of additional pain control at 60 minutes.	Drug: Acetaminophen 1000mg IV; 1000mg of IV acetaminophen in 100ml of normal saline, administered as an intravenous drip over 10 minutes + 2ml of normal saline, administered as a slow intravenous push
Active Comparator: Hydromorphone 0.5mg IV; NRS pain score will be checked at 5 minutes and every 15 minutes thereafter for 120 minutes. Adverse events will be recorded every 15 minutes for the duration of the study protocol. The need for additional pain control will be assessed at 60 minutes.	Drug: Hydromorphone 0.5 mg IV; 100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in 2ml of normal saline, administered as a slow intravenous push

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Improvement in NRS Pain Score	Pain improvement was assessed using an NRS (numeric rating scale) to assess pain on a range of 0-10. Participants were asked to verbalize intensity of pain on the scale with zero meaning "no pain" and 10 meaning "the worst pain imaginable." Pain was assessed at baseline and 60 minutes later to determine if clinically important improvement in pain was achieved. Clinically important improvement in pain was defined as an improvement of >=1.3 points on the 0-10 scale.	60 minutes following administration of medication

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for Rescue Medication	Number of participants who required additional analgesic medication for the treatment of pain at any time during their ED course.	120 minutes following administration of medication
Improvement in NPS Pain Score by >=50%	The number of patients who minimally achieved a 50% improvement in NPS pain score from 0 to 60 minutes.	60 minutes after administration of medication

Collaborators and Investigators

• Sponsor: Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2018
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): March 23, 2022

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Acetaminophen; Hydromorphone
• Other Study ID Numbers: 2018-8876

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes